A Phase 1, Open-label Trial of Belzupacap Sarotalocan (AU-011) in Bladder Cancer

Summary

The main objectives of this study are to determine the feasibility and safety of Belzupacap Sarotalocan (AU-011, bel-sar) treatment of bladder cancer utilizing focal injections with or without laser application.

Eligibility

Inclusion Criteria:

1. Meet the following histopathologic requirements for urothelial carcinoma:

   * For Cohorts 1b, 4a-c:

   histopathological diagnosis of NMIBC (any grade) is required. For participants with first diagnosis of NMIBC, confirmation of urothelial carcinoma by recent biopsy (≤6 months of Screening Visit) is required. Participants with recurrent NMIBC must have a current lesion that clinically appears to be NMIBC with histopathologic confirmation based on TURBT or biopsy within the last 24 months).

   For Cohorts 4d, 4e, 4g and 4h, a diagnosis of LG IR NMIBC (according to

   AUA risk classification guidelines) is required, specifically:
   * Multifocal LG Ta; OR
   * Solitary LG Ta \>3 cm; OR
   * Low-grade Ta with prior recurrence(s) within 1 year.

   For Cohorts 4f and 4i, a diagnosis of HR NMIBC (according to AUA risk classification guidelines) is required, specifically:
   * Ta HG papillary disease with or without CIS; OR
   * T1 papillary disease with or without CIS
   * Participants may be BCG-naïve or may have received prior treatment with BCG for HR or IR NMIBC (BCG-exposed, BCG-failed, BCG-intolerant)
   * BCG-refractory participants are excluded. BCG-refractory is defined by the following:

     * Persistent HG disease at 6 months following adequate BCG (defined as ≥5/6 induction instillations and ≥2 additional doses, either from re-induction or maintenance), OR
     * HG T1 disease at first evaluation (3 months) after BCG, OR
     * Persistent CIS that remains despite a second BCG course, OR
     * Disease progression in stage or grade during BCG therapy, including maintenance
2. Have no evidence of current or prior metastatic urothelial carcinoma
3. Adequate bone marrow, renal, and hepatic function

Exclusion Criteria:

1. Any additional malignancy that requires active treatment, unless deemed appropriate after discussion by the Investigator with the trial's Medical Monitor.
2. Used an investigational drug or medical device within 30 days or 5 half-lives (whichever is longer) of Visit 1 or be concurrently enrolled in another investigational trial.
3. Active bacterial, fungal, or viral infections - all prior infections must have resolved following optimal therapy and subject must be off all systemic anti-infective agents.
4. Active autoimmune disease, chronic inflammatory condition, or other conditions (like solid organ transplant or bone marrow allograft) requiring concurrent use of any systemic immunosuppressants or steroids.
5. Chronic active hepatitis B or C and HIV.

Conditions8

Locations11 sites

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